Updated results from the phase 3 HELIOS study of ibrutinib,
bendamustine, and rituximab in relapsed chronic lymphocytic
leukemia/small lymphocytic lymphoma

J 2019

Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI et. al.

Základní údaje

Originální název

Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma

Autoři

FRASER, G. (124 Kanada), P. CRAMER (276 Německo), F. DEMIRKAN (792 Turecko), R.S. SILVA (76 Brazílie), S. GROSICKI (616 Polsko), A. PRISTUPA (643 Rusko), A. JANSSENS (56 Belgie), Jiří MAYER (203 Česká republika, domácí), N.L. BARTLETT (840 Spojené státy), M.S. DILHUYDY (250 Francie), H. PYLYPENKO (804 Ukrajina), J. LOSCERTALES (724 Španělsko), A. AVIGDOR (376 Izrael), S. RULE (826 Velká Británie a Severní Irsko), D. VILLA (124 Kanada), O. SAMOILOVA (643 Rusko), P. PANAGIOTIDIS (300 Řecko), A. GOY (840 Spojené státy), M.A. PAVLOVSKY (32 Argentina), C. KARLSSON (752 Švédsko), M. HALLEK (276 Německo), M. MAHLER (840 Spojené státy), M. SALMAN (840 Spojené státy), S. SUN (840 Spojené státy), C. PHELPS (840 Spojené státy), S. BALASUBRAMANIAN (840 Spojené státy), A. HOWES (826 Velká Británie a Severní Irsko) a A. CHANAN-KHAN (826 Velká Británie a Severní Irsko)

Vydání

Leukemia, London, Nature Publishing Group, 2019, 0887-6924

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 8.665

Kód RIV

RIV/00216224:14110/19:00109488

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1038/s41375-018-0276-9

UT WoS

000463162400012

Klíčová slova anglicky

ibrutinib; bendamustine; rituximab

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 18. 4. 2019 11:29, Soňa Böhmová

Anotace

V originále

We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1: 1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159-0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454-0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 34) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.

Citovat

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří MAYER, N.L. BARTLETT, M.S. DILHUYDY, H. PYLYPENKO, J. LOSCERTALES, A. AVIGDOR, S. RULE, D. VILLA, O. SAMOILOVA, P. PANAGIOTIDIS, A. GOY, M.A. PAVLOVSKY, C. KARLSSON, M. HALLEK, M. MAHLER, M. SALMAN, S. SUN, C. PHELPS, S. BALASUBRAMANIAN, A. HOWES a A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia. London: Nature Publishing Group, 2019, roč. 33, č. 4, s. 969-980. ISSN 0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-018-0276-9.

@article{1522776,
   author = {Fraser, G. and Cramer, P. and Demirkan, F. and Silva, R.S. and Grosicki, S. and Pristupa, A. and Janssens, A. and Mayer, Jiří and Bartlett, N.L. and Dilhuydy, M.S. and Pylypenko, H. and Loscertales, J. and Avigdor, A. and Rule, S. and Villa, D. and Samoilova, O. and Panagiotidis, P. and Goy, A. and Pavlovsky, M.A. and Karlsson, C. and Hallek, M. and Mahler, M. and Salman, M. and Sun, S. and Phelps, C. and Balasubramanian, S. and Howes, A. and ChananandKhan, A.},
   article_location = {London},
   article_number = {4},
   doi = {http://dx.doi.org/10.1038/s41375-018-0276-9},
   keywords = {ibrutinib; bendamustine; rituximab},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma},
   url = {http://dx.doi.org/10.1038/s41375-018-0276-9},
   volume = {33},
   year = {2019}
}

TY  - JOUR
ID  - 1522776
AU  - Fraser, G. - Cramer, P. - Demirkan, F. - Silva, R.S. - Grosicki, S. - Pristupa, A. - Janssens, A. - Mayer, Jiří - Bartlett, N.L. - Dilhuydy, M.S. - Pylypenko, H. - Loscertales, J. - Avigdor, A. - Rule, S. - Villa, D. - Samoilova, O. - Panagiotidis, P. - Goy, A. - Pavlovsky, M.A. - Karlsson, C. - Hallek, M. - Mahler, M. - Salman, M. - Sun, S. - Phelps, C. - Balasubramanian, S. - Howes, A. - Chanan-Khan, A.
PY  - 2019
TI  - Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
JF  - Leukemia
VL  - 33
IS  - 4
SP  - 969-980
EP  - 969-980
PB  - Nature Publishing Group
SN  - 08876924
KW  - ibrutinib
KW  - bendamustine
KW  - rituximab
UR  - http://dx.doi.org/10.1038/s41375-018-0276-9
L2  - http://dx.doi.org/10.1038/s41375-018-0276-9
N2  - We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1: 1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159-0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454-0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 34) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.
ER  -

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří MAYER, N.L. BARTLETT, M.S. DILHUYDY, H. PYLYPENKO, J. LOSCERTALES, A. AVIGDOR, S. RULE, D. VILLA, O. SAMOILOVA, P. PANAGIOTIDIS, A. GOY, M.A. PAVLOVSKY, C. KARLSSON, M. HALLEK, M. MAHLER, M. SALMAN, S. SUN, C. PHELPS, S. BALASUBRAMANIAN, A. HOWES a A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. \textit{Leukemia}. London: Nature Publishing Group, 2019, roč.~33, č.~4, s.~969-980. ISSN~0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-018-0276-9.

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